A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK0518 Versus KALETRA in HIV-Infected Patients Switched From a Stable KALETRA-Based Regimen - Study B
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 355
- 主要终点
- Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
研究概览
简要总结
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with Human Immunodeficiency Virus (HIV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years of age
- •Patient is human immunodeficiency virus (HIV) positive
- •Patient has documented Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 copies/milliliter (mL) for at least 3 months while on a KALETRA based regimen
- •Patient has been on a KALETRA based regimen for at least 3 months without a change in background antiretroviral therapy
- •Patient has no documentation of HIV RNA >50 copies/mL for at least 3 months while on the KALETRA based regimen
排除标准
- •Patient is or plans to become pregnant, or is nursing a child
- •Patient plans to donate eggs or impregnate/donate sperm
- •Patient is receiving Stavudine (d4T) as a component of the background antiretroviral therapy
- •Patient is currently receiving a second protease inhibitor in addition to KALETRA
- •Patient is currently receiving, or has received in the past twelve weeks, treatment for the management of elevated lipids
- •Patient has used another experimental HIV-integrase inhibitor
- •Patient has a current (active) diagnosis of acute hepatitis due to any cause
结局指标
主要结局
Number of Patients With Plasma Human Immunodeficiency Virus (HIV) RiboNucleic Acid (RNA) <50 Copies/mL at Week 24
时间窗: 24 Weeks
Number of Patients With Clinical Adverse Experiences (CAEs) Through 24 Weeks
时间窗: 24 Week last patient last visit
Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 12
时间窗: Baseline and Week 12
Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 12
时间窗: Baseline and Week 12
Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
时间窗: Baseline and Week 12
Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 12
时间窗: Baseline and Week 12
Median Percent Change From Baseline in Serum Triglyceride at Week 12
时间窗: Baseline and Week 12
Standard Deviation (Robust): calculated as interquartile range (IQR)/1.075, where IQR=3rd quartile-1st quartile.
次要结局
- Mean Percent Change From Baseline in Fasting Serum Cholesterol at Week 24(Baseline and Week 24)
- Mean Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24(Baseline and Week 24)
- Mean Percent Change From Baseline in Fasting Serum Low-density Lipoprotein Cholesterol (LDL-C) at Week 24(Baseline and Week 24)
- Mean Percent Change From Baseline in Fasting Serum High-density Lipoprotein Cholesterol (HDL-C) at Week 24(Baseline and Week 24)
- Median Percent Change From Baseline in Serum Triglyceride at Week 24(Baseline and Week 24)